Bristol Taxol orphan designation for Kaposi's is pending: hurdle for Ivax' Paxene?.
BRISTOL TAXOL ORPHAN DESIGNATION REQUEST COULD BLOCK IVAX from marketing its pending paclitaxel brand Paxene for Kaposi's sarcoma. Ivax filed a full NDA for Paxene for KS on March 31 ("The Pink Sheet" April 7, T&G-2). Bristol submitted a supplemental NDA covering use of Taxol for the indication on Feb. 5, the company said. A request for orphan designation was filed Feb. 4, although the company has not received a decision from FDA.
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